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The approval of Aduhelm risks eroding public trust in Alzheimer research and the FDA

Nature Reviews Neurology volume 17, pages 523–524 (2021)Cite this article

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The FDA has granted accelerated approval to aducanumab (Aduhelm) for the treatment of Alzheimer disease with an overly broad label. The decision disregarded key aspects of scientific process and risks eroding public trust in research, regulatory science and the FDA.

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References

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Authors and Affiliations

  1. Departments of Medicine, Medical Ethics and Health Policy, and Neurology, Perelman School of Medicine, The University of Pennsylvania, Philadelphia, PA, USA

    Jason Karlawish

  2. Departments of Psychiatry & Human Behavior and Neurobiology & Behavior, Institute for Memory Impairments and Neurological Disorders, The University of California Irvine, Irvine, CA, USA

    Joshua D. Grill

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  1. Jason Karlawish
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  2. Joshua D. Grill
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The authors contributed equally to all aspects of the article.

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Correspondence to Jason Karlawish.

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Competing interests

J.K. is a site investigator for studies sponsored by Biogen, Eisai and Eli Lilly. J.D.G. receives research support from Biogen, Eisai, Eli Lilly and Genentech; and consulting fees from Cogniciti, Flint Rehab and SiteRx.

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Karlawish, J., Grill, J.D. The approval of Aduhelm risks eroding public trust in Alzheimer research and the FDA. Nat Rev Neurol 17, 523–524 (2021). https://doi.org/10.1038/s41582-021-00540-6

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